U.S. patent number 8,801,655 [Application Number 13/705,638] was granted by the patent office on 2014-08-12 for wearable insulin dispensing device, and a combination of such a device and a programming controller.
This patent grant is currently assigned to Asante Solutions, Inc.. The grantee listed for this patent is Asante Solutions, Inc.. Invention is credited to Michael Gorm Lyngsie, Morten Mernoe.
United States Patent |
8,801,655 |
Mernoe , et al. |
August 12, 2014 |
Wearable insulin dispensing device, and a combination of such a
device and a programming controller
Abstract
A disposable, wearable, self-contained insulin dispensing device
includes a housing and an insulin source in the housing that is
connected to a catheter for injecting insulin into a user.
Inventors: |
Mernoe; Morten (Charlottenlund,
DK), Lyngsie; Michael Gorm (Gentofte, DK) |
Applicant: |
Name |
City |
State |
Country |
Type |
Asante Solutions, Inc. |
Sunnyvale |
CA |
US |
|
|
Assignee: |
Asante Solutions, Inc.
(Sunnyvale, CA)
|
Family
ID: |
32668636 |
Appl.
No.: |
13/705,638 |
Filed: |
December 5, 2012 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20130102964 A1 |
Apr 25, 2013 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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12818830 |
Jun 18, 2010 |
8469920 |
|
|
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11157479 |
Aug 31, 2010 |
7785288 |
|
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PCT/DK03/00916 |
Dec 19, 2003 |
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11121708 |
Feb 15, 2011 |
7887511 |
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PCT/DK03/00753 |
Nov 4, 2003 |
|
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Foreign Application Priority Data
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Nov 5, 2002 [DK] |
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2002 01702 |
Dec 23, 2002 [DK] |
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2002 02006 |
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Current U.S.
Class: |
604/65 |
Current CPC
Class: |
A61M
5/172 (20130101); A61M 5/14248 (20130101); A61M
5/1452 (20130101); A61M 5/14566 (20130101); A61M
5/158 (20130101); A61M 5/14546 (20130101); A61M
2005/3109 (20130101); A61M 2005/14268 (20130101); A61M
2205/0266 (20130101); A61M 2205/3592 (20130101); A61M
2205/0238 (20130101); A61M 2205/581 (20130101); A61M
2202/04 (20130101); A61M 2005/1581 (20130101); A61M
2005/31518 (20130101) |
Current International
Class: |
A61M
31/00 (20060101) |
Field of
Search: |
;604/131,65-67,151
;128/DIG.12,DIG.13 |
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|
Primary Examiner: Mendez; Manuel
Attorney, Agent or Firm: Fish & Richardson P.C.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser.
No. 12/818,830 (now U.S. Pat. No. 8,469,920) filed on Jun. 18,
2010, which is a continuation of U.S. patent application Ser. No.
11/157,479 (now U.S. Pat. No. 7,785,288) filed on Jun. 21,
2005,which is (i) a continuation of International Application No.
PCT/DK2003/000916 (Pub. No. WO2004/056412), filed Dec. 19, 2003,
which claims priority to Denmark Patent Application No. 200202006
filed on Dec. 23, 2002, and (ii) a continuation-in-part of U.S.
application Ser. No. 11/121,708 (now U.S. Pat. No. 7,887,511),
filed May 4, 2005, which is a Continuation of International
Application No. PCT/DK2003/000753 (Pub. No. WO2004/041330), filed
Nov. 4, 2003, which claims priority to Denmark Patent Application
No. 200201702 filed on Nov. 5, 2002. The disclosures of all of the
aforesaid related applications are incorporated herein by
reference.
Claims
The invention claimed is:
1. A medicine dispensing system, comprising: a wearable pump
housing assembly including a lower portion for releasably coupling
with a skin surface, the wearable pump housing assembly containing
a generally cylindrical insulin reservoir in an interior space such
that the generally cylindrical insulin reservoir extends in a
longitudinal direction along a length of the wearable pump housing
assembly; a piston rod movably arranged in the housing assembly to
dispense insulin from the generally cylindrical insulin reservoir;
a drive system to advance the piston rod toward the generally
cylindrical insulin reservoir; a bolus push button arranged on the
wearable pump housing assembly so as to activate a bolus dispensing
operation in which a bolus dosage of insulin is dispensed from the
generally cylindrical insulin reservoir; a control circuit in the
pump housing assembly to communicate drive signals to the drive
system to cause the dispensation of the insulin, the control
circuit including: a programmable unit that stores a programmed
dosage schedule, and a wireless communication receiver; and a
wireless controller to communicate signals to the control circuit
in the pump housing assembly indicative of the programmed dosage
schedule, wherein the wireless controller includes a user interface
display screen and is configured to receive user input of glucose
level measurements.
2. The system of claim 1, further comprising an infusion interface
catheter that is attachable to the wearable pump housing assembly,
the infusion interface catheter being configured to penetrate
through the skin surface, wherein the infusion interface catheter
communicates insulin dispensed from the insulin reservoir.
3. The system of claim 2, further comprising an adhesive layer
coupled to a lower planar surface of the lower portion of the pump
housing assembly to secure the pump housing assembly to the skin
surface.
4. The system of claim 3, further comprising a removable release
sheet to cover the adhesive layer.
5. The system of claim 2, wherein the piston rod comprises a
flexible piston rod movably arranged in the housing assembly to
adjust from a curved configuration to a generally longitudinally
straight configuration so as to dispense medicine from the
generally cylindrical insulin reservoir, the flexible piston rod
comprising rod segments connected in series by hinge elements, the
rod segments having exterior threads on at least a portion of an
outer surface.
6. The system of claim 1, wherein the drive system comprises a
shape memory alloy wire that changes length in response to
heat.
7. The system of claim 1, wherein the drive system comprises a gear
wheel, a pawl arranged to engage at least one tooth of the gear
wheel, and a spring device coupled to the pawl so as to urge the
pawl to rotate the gear wheel.
8. The system of claim 1, wherein the control circuit communicates
the drive signals according to a program that indicates a sequence
of a particular amount of actuations of the drive system over a
period of time.
9. The system of claim 8, wherein the program indicates a sequence
of actuations of the drive system that varies according to the time
of day.
10. The system of claim 9, wherein the program is indicative of the
programmed dosage schedule and is stored in the programmable unit
of the control circuit, the program being alterable by input on the
user interface of the wireless controller.
11. The system of claim 1, wherein the wireless controller
comprises a cellular phone device.
12. The system of claim 1, wherein the wireless controller
comprises a personal computer device.
13. The system of claim 1, wherein the wireless controller
comprises a laptop computer device.
14. The system of claim 1, wherein the wireless controller
comprises a handheld computer device.
15. The system of claim 1, wherein the piston rod comprises a
flexible piston rod movably arranged in the housing assembly to
adjust from a curved configuration to a generally longitudinally
straight configuration so as to dispense medicine from the
generally cylindrical insulin reservoir, the flexible piston rod
comprising rod segments connected in series by hinge elements, the
rod segments having exterior threads on at least a portion of an
outer surface.
16. The system of claim 15, wherein the exterior threads of the rod
segments cooperate with corresponding screw threads of a component
of the drive system.
17. The system of claim 15, wherein the rod segments and hinge
elements are integrally molded as a unitary structure from a
plastic material.
18. The system of claim 1, wherein the housing assembly provides
water-tight containment for the generally cylindrical insulin
reservoir.
19. The system of claim 1, further comprising an audio speaker
coupled to the wearable pump housing assembly for emitting sounds
in response to actuation of the bolus push button.
Description
BACKGROUND
The present invention relates generally to wearable medicine
dispensing devices, particularly insulin dispensing devices.
In connection with injection of insulin for treating Type I and
Type II Diabetes extremely important features are simplicity of
operation, reliability, cost and flexibility, which all are related
to the issue of compliance which particularly in the cases of
relatively mild Type II diabetes is a problem with important
consequences regarding the success rate in treating the
patients.
SUMMARY
The main object of the invention is to provide a wearable medicine,
particularly insulin dispensing device having features and
operation characteristics supporting and easing compliance by the
users of the device.
The present invention provides a disposable, wearable,
self-contained medicine, particularly insulin dispensing device
comprising a housing, an insulin source in said housing, a pump
means in said housing and adapted for pumping insulin from said
insulin source to a catheter for injection of said insulin in a
user of the device and, said catheter being associated with said
housing and projecting generally perpendicularly to a generally
planar surface of said housing intended for abutting a skin surface
of a user of the device, an adhesive layer provided on said planar
surface for adhering said planar surface to said skin surface, and
a removable release sheet covering said adhesive layer for
protecting said adhesive layer prior to use of said dispensing
device, said release sheet being provided with catheter protection
means to enclose and protect an end portion of said catheter such
that removal of said release sheet for exposing said adhesive layer
exposes said end portion.
Hereby, in a simple, reliable and cost-effective manner a device is
provided which is easy to apply and still in an effective manner
protects the catheter against damage and contamination until use of
the device is initiated.
In another aspect, the invention provides a disposable, wearable,
self-contained medicine, particularly insulin dispensing device
comprising a housing, an insulin source in said housing, a pump
means in said housing and adapted for pumping insulin from said
insulin source to a catheter for injection of said insulin in a
user of the device and, said catheter being associated with said
housing and projecting generally perpendicularly to a generally
planar surface of said housing intended for abutting a skin surface
of a user of the device, an adhesive layer provided on said planar
surface for adhering said planar surface to said skin surface, a
combined microphone and loudspeaker associated with said housing,
preferably arranged inside said housing, and recording and play
back means connected to said combined microphone and loudspeaker
and associated with said housing, preferably arranged inside said
housing, such that verbal messages may be recorded and played back
by said dispensing device.
Hereby a device promoting simple communication between a health
care provider and the user is provided with readily understandable
operation and with good effect on the compliance rate.
In yet another aspect, the invention provides a disposable,
wearable, self-contained medicine, particularly insulin dispensing
device comprising a housing, an insulin source in said housing, a
pump means in said housing and adapted for pumping insulin from
said insulin source to a catheter for injection of said insulin in
a user of the device, and an actuator for said pump means, said
actuator comprising a shape memory alloy wire, said actuator
preferably further comprising a ratchet gear or pawl wheel, a pawl
adapted for co-operating with said pawl wheel and connected to one
end of said shape memory alloy wire and a spring means connected to
said pawl, the connections between said pawl and said wire and said
pawl and said spring means being such that contraction of said wire
rotates said pawl wheel against the spring force of said spring
means.
Hereby a pump means requiring very low energy and with a high
degree of reliability is provided at a relatively low cost.
In a yet further aspect, the invention relates to a disposable,
wearable, self-contained medicine, particularly insulin dispensing
device comprising a housing, an insulin source in said housing, a
pump means in said housing and adapted for pumping insulin from
said insulin source to a catheter for injection of said insulin in
a user of the device, an actuator for said pump means, preferably
an actuator comprising a shape memory alloy wire, and controlling
means for controlling the operation of said actuator according to a
program, said program consisting in a sequence of a certain amount
of actuations of said actuator per 24 hour time periods, or, in
connection with provision of a timing means connected to said
controlling means said program consisting in a sequence of
actuations of said actuator that varies according to the time of
day or, in connection with provision of a timing means connected to
said controlling means and an input device for inputting data to
said controlling means, adapting said controlling means so as to be
programmable by means of said data, or adapting said program of
said controlling means to comprise algorithms for automatically
altering the sequence of actuations of said actuator according to
input of data relative to the actual glucose level in the blood of
the user of the device and/or intake of nutrients by said user.
Hereby, compliance is enhanced by providing a device with
capabilities of rendering a very specific and well-tuned dosage
which may be altered according to the specific development of the
individual user.
So as to achieve a compact dispensing device, the pump means may
comprise a piston rod for displacing a piston in a cylindrical
container of said medicine to be dispensed and an actuator for
displacing said piston rod, wherein said piston rod is configured
such that the portion of said piston rod between said actuator and
said piston is rectilinear and rest of said piston rod is arcuate,
and such piston rod may comprise elements arranged in a row and
interconnected by hinge elements, wherein each element is provided
with a surface spaced from said hinge element and configured to
abut a corresponding surface of an adjacent element when said
piston rod is rectilinear, and said elements may be provided with
screw threads on the outer surface thereof for co-operating with
corresponding screw threads of the actuator.
In an alternative embodiment such piston rod may comprise a strip
having an arcuate cross section taken transverse to the
longitudinal direction of said strip which is rectilinear between
said actuator and said piston while the rest of the strip is wound
into a roll. The strip may be provided with apertures, preferably
transversely extending slits, evenly spaced along the length
thereof for receiving corresponding projections of said
actuator.
In a yet further aspect, the invention relates provides a
combination of a dispensing device as specified above and a
programming controller, said dispensing device and said programming
controller comprising co-operating transmission and/or receiving
means for mutual communication of data, said programming controller
preferably being a cellular telephone or a personal computer or a
laptop computer or a hand held computer.
Moreover, the invention provides a method of controlling the
operation of a disposable, wearable, self-contained medicine,
particularly insulin dispensing device comprising a housing, an
insulin source in said housing, a pump means in said housing and
adapted for pumping insulin from said insulin source to a catheter
for injection of said insulin in a user of the device, an actuator
for said pump means, preferably an actuator comprising a shape
memory alloy wire, and controlling means for controlling the
operation of said actuator according to a program, said method
comprising the steps of: providing said controlling means with data
for generating and/or amending said program prior to and/or after
initiation of use of said dispensing device.
Furthermore, in a yet other aspect, the invention also relates to a
method of controlling the operation of a disposable, wearable,
self-contained medicine, particularly insulin dispensing device
comprising a housing, an insulin source in said housing, a pump
means in said housing and adapted for pumping insulin from said
insulin source to a catheter for injection of said insulin in a
user of the device and, said catheter being associated with said
housing and projecting generally perpendicularly to a generally
planar surface of said housing intended for abutting a skin surface
of a user of the device, an adhesive layer provided on said planar
surface for adhering said planar surface to said skin surface, a
combined microphone and loudspeaker associated with said housing,
preferably arranged inside said housing, recording and play back
means connected to said combined microphone and loudspeaker and
associated with said housing, preferably arranged inside said
housing, such that verbal messages may be recorded and played back
by said dispensing device, and manual operating means for manually
controlling the operation of said dispensing device said method
comprising the steps of: recording verbal instructions in said
recording means for instructing the user of the device in the
operation of said dispensing device, and playing back said verbal
instructions.
Finally, the invention relates to a method of controlling the
operation of a disposable, wearable, self-contained medicine,
particularly insulin dispensing device comprising a housing, an
insulin source in said housing, a pump means in said housing and
adapted for pumping insulin from said insulin source to a catheter
for injection of said insulin in a user of the device and, said
catheter being associated with said housing and projecting
generally perpendicularly to a generally planar surface of said
housing intended for abutting a skin surface of a user of the
device, an adhesive layer provided on said planar surface for
adhering said planar surface to said skin surface, a combined
microphone and loudspeaker associated with said housing, preferably
arranged inside said housing, a programmable computing means
associated with said housing, preferably arranged inside said
housing, and signal conversion means connected to said combined
microphone and loudspeaker and associated with said housing,
preferably arranged inside said housing, and adapted for converting
received audio signals into input signals for said computing means
and for converting output signals from said computing means to
audio signals, said method comprising one or more of the steps of:
transmitting audio signals to said microphone for controlling the
operation of said dispensing device, receiving audio signals from
said loudspeaker for evaluating the operation of said dispensing
device.
In the following, the invention will be described and explained
more in detail in connection with various embodiments of an insulin
dispensing device according to the invention shown, solely by way
of example, in the accompanying drawings where:
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic isometric view of a first embodiment of a
disposable insulin dispensing device according to the invention
before the adhesive pad for adhering the device to the skin of a
user has been mounted on the device,
FIG. 2 is a schematic isometric view of the device of FIG. 1 seen
from another angle and with the adhesive pad mounted thereon,
FIG. 3 is a schematic isometric partly exploded view of the device
of FIG. 2,
FIG. 4 is a schematic entirely exploded view of the device of FIG.
2,
FIG. 5 is a schematic isometric view of the device of FIG. 2
together with a programming device according to the invention,
FIG. 6 is a schematic enlarged scale exploded view of a shape
memory alloy actuator mechanism according to the invention of the
device of FIG. 2,
FIG. 7 is a schematic view corresponding to FIG. 6 with the
elements of the shape memory actuator shown in interconnected
operative relative positions,
FIG. 8 is a schematic isometric view of a second, more compact
embodiment of a disposable insulin dispensing device according to
the invention,
FIG. 9 is a schematic, isometric view of the device of FIG. 8 with
the top removed so as to illustrate the co-operating elements of
the device,
FIG. 10 is a schematic, isometric view of the device of FIG. 8 seen
from another angle than FIG. 9,
FIG. 11 is a schematic exploded view of the device of FIGS.
8-10,
FIGS. 12a-12c are very schematic views, seen in the direction of
the axis of the carpule, of the operation of the drive mechanism of
the device of FIGS. 8-11 illustrating the interaction of the pawl
or ratchet wheel with the spring elements and the shape memory
alloy wire,
FIGS. 13, 14A-C, and 15 are schematic views illustrating a first
embodiment of an actuator with a flexible piston rod according to
the invention for use in a compact dispensing device according to
the invention,
FIG. 16 is a schematic isometric view illustrating a second
embodiment of an actuator with a flexible piston rod according to
the invention for use in a compact dispensing device according to
the invention, and
FIGS. 17-19 are graphs illustrating different insulin dispensing
programs.
DETAILED DESCRIPTION
Generally speaking, although the device according to the invention
is primarily intended for dispensing insulin, it may also be used
for dispensing other medicinal substances such as pain-killers,
anti-biotics and so on, such that whenever the term insulin is used
herein, any other dispensable medicine is intended to be covered by
the term insulin unless not applicable either by explicit
indication or by implicit indication owing to the context wherein
the term insulin is employed. Furthermore, it should be noted that
when the term carpule is utilized, it is not in any way limited by
the WIPO resolutions or any trademark interpretation but is used to
denote any cartridge, container, ampoule etc. suitable for storing
and dispensing medicinal compounds.
Referring now to FIG. 1, a disposable insulin dispensing device
according to the invention, generally referenced by the numeral 1,
comprises a water-tight generally cylindrical housing 2 provided
with a push button 3 for activating and deactivating the device as
well as for activating a so-called bolus operation as explained in
the following.
The housing further comprises a transparent window 4 for inspecting
the operation of the device and apertures 5 for transmission of
sound waves as explained in the following.
At one end of the housing 2 there is provided a stiletto 6 having a
sharp needle 7 extending through a catheter 8 connected to a not
shown insulin container or carpule inside the housing 2 as
explained in the following.
Referring now to FIGS. 2-3, the housing 2 is fixedly received in a
trough 9 of an adhesive pad 10 made of a combination of a plate 11
of skin-friendly adhesive material, for instance as well known in
the field of ostomy pouches, see for instance European patent
application no. 0413250 and European patent application no.
0092999, and a relatively compressible portion 10a made of foam
material attached to the plate 11. The catheter 8 extends through
the planar portion 11 of the pad 10. The push button 3 is protected
by the foam material 10a so as to avoid inadvertent operation of
the button for instance when the user is asleep.
A slip release film 12 is adhered to the bottom surface of the
adhesive plate 11 for protecting the adhesive surface of the plate
11 such that the adhesive properties are intact when the pad is to
be adhered to the skin of a user of the dispensing device. The
release film 12 is provided with a protective hollow projection 13
for receiving the catheter 8 and the needle 7 of the stiletto 6 so
that the needle 7 and the catheter 8 are protected by the
projection 13 before use of the dispensing device 1. The housing 2
is provided with an end cover 14 on which the catheter 8 is mounted
by means of a communication bushing 15 provided with an internal
elastomeric mass (not shown) and a communication passage for
communicating the catheter 8 with the interior of the housing 2 as
explained in the following in connection with FIG. 4.
In use, the user removes the protective release sheet 12 thereby
exposing the tip of the needle 7 such that the needle may be
inserted subcutaneously at the same time that the adhesive pad 10a,
11 is adhered to the abdominal skin of the user. When the needle 7
and the catheter 8 have been inserted subcutaneously and the device
has been adhered to the skin of the user, the stiletto 6 is removed
whereby communication is established between the catheter 8 and the
interior of the housing 2 for supplying insulin subcutaneously to
the user of the device.
The elastomeric mass in the bushing 15 seals the exit opening of
the needle 7 when it is removed such that no insulin may leak
through said exit opening but is constrained to flow solely from
the carpule to the catheter 8.
Referring now to FIG. 4 showing an exploded view of the components
of the insulin dispensing device according to the invention, the
housing 2 contains a container or a carpule 16 for storing and
dispensing insulin. The container or carpule 16 is of a well-known
type having a perforatable dispensing projection 17 for receiving a
catheter 18 for communicating the interior of the container 16 with
the catheter 8 through the communication bushing 15 when the needle
7 has been retracted from said elastomeric mass inside the bushing
15 as explained above.
A spindle 19 provided with a piston 20 is received in the container
16 such that axial displacement of the spindle towards the
dispensing projection 17 will press insulin through the catheter 18
to the catheter 8. The spindle 19 is rotated and displaced by means
of a shape memory alloy actuator described more in detail in the
following with reference to FIG. 6.
A battery 21 for supplying power to the shape memory actuator is
provided adjacent an end cover 22 of the housing 2.
The shape memory actuator comprises a pawl or ratchet wheel 23, a
guide bushing 24, a spring wheel 25 and a shape memory wire 26. The
operation of the shape memory actuator will be described more in
detail in the following with reference to FIGS. 6 and 7.
A printed circuit board 27 is provided for controlling the function
of the dispensing device and the various operational steps thereof
as described in the following.
Finally a combined microphone/loudspeaker 28 is arranged inside the
housing 2 adjacent the apertures 5 for receiving and emitting sound
waves for the purposes described below.
Referring now to FIG. 5, a programming device or controller 29
having programming keys 30 and a display 31 is shown proximate the
dispensing device for communicating with a not shown
receiver/transmitter arranged inside the housing 2. The
communication may take place by infra red signals or other suitable
signals transmitted from and to an opening 32 leading to a
transmitter/receiver inside the controller 29 to and from,
respectively an opening 33 (see FIG. 2) in the end cover 22 of the
housing 2 leading to said not shown transmitter/receiver inside the
housing 2.
Referring now to FIGS. 6 and 7, the spindle 19 is displaced axially
in the direction of the arrow R1 by counter-clockwise rotation of
the pawl wheel 23 in the direction of the arrow R2 whereby the
thread 36 meshing with the internal thread 37 results in said axial
displacement whereby the piston 20 is displaced further into the
carpule 16 to dispense insulin through the catheter 18 to the
catheter 8 (FIG. 4).
Rotation of the pawl wheel 23 is accomplished by means of the shape
memory alloy (for instance Nitinol) wire 26 attached to
electrically conductive rods 38 and 39 that are fixed in recesses
40 and 41, respectively, in the electrically non-conductive guide
bushing 24 and the electrically conductive spring wheel 25,
respectively.
The recess 40 is provided with not shown electrical contacts for
electrically connecting the rod 39 to the battery 21 for supplying
electrical current to the shape memory alloy (SMA) wire 26 to heat
it in a manner and sequence controlled by the program elements in
the printed circuit board 27.
The spring wheel 25 has U-shaped spring arms 44 and 45 for exerting
a spring force on the ends 46 and 47 thereof, respectively, in a
direction towards the center of the pawl wheel 23 such that the
ends 46 and 47 are constantly biased to enter into engagement with
the teeth of the pawl wheel 23.
The stop pins 42 and 43 are electrically connected to the printed
circuit board 27 for emitting an electrical signal thereto when the
spring wheel arm 48 contacts said stop pins.
The rod 38 is as mentioned above electrically connected to the
power source such that an electrical current may be passed through
the rod 38, the wire 26, the rod 39, the loop recess 41 and the
spring wheel 25 to heat the wire 26 to cause the wire to contract
and rotate the pawl wheel the distance of one tooth in the
direction of arrow R2 by means of the arm end 46 engaging a tooth
of the wheel until the arm 48 contacts the stop pin 42 that emits a
signal to the control printed circuit board 27 whereby the current
through the wire 26 is interrupted and the SMA wire 26 cools off
and expands.
The other arm end 47 engages a tooth of the wheel 23 as a pawl and
prevents the wheel 23 from rotating clock-wise. The spring effect
of the spring wheel 25 in the tangential direction causes the arm
42 to move back into contact with the stop pin 43 thereby
tightening the expanded SMA wire 26.
The signals from the stop pins 42 and 43 are also utilized to
indicate correct functioning of the pump and as an indication of
the number of doses administered through the catheter 8.
Referring now to FIGS. 8-12, a second, more compact, embodiment of
a medicine pump 51 according to the invention comprises a housing
upper portion 52 and a housing lower portion 53, the upper portion
52 having audio apertures 54 for allowing audio signals to travel
relatively unencumbered through the wall of the upper portion 52
from and to an audio element 54a, a bolus button aperture 55 for
allowing depression of a bolus button 56 and an inspection aperture
57 covered by a transparent element 57a for allowing monitoring of
the contents of an insulin carpule 58 provided inside the
housing.
The lower housing portion 53 is adhered to an adhesive pad 59
covered by a release sheet with a needle protection projection or
indentation 61 very similar to the corresponding elements of the
embodiment of FIGS. 1-4. The carpule 58 co-operates with a
catheter/stiletto assembly 62 in the same manner as described in
connection with the embodiment of FIGS. 1-4.
The embodiment of FIGS. 8-12 is very similar in construction and in
operation to the embodiment of FIGS. 1-4 with the exception of the
rigid rectilinear spindle or piston rod 19 being substituted by a
flexible piston rod 63 according to the invention and the design of
the shape memory alloy wire actuator as will be described in the
following.
A piston 64 corresponding to piston 20 of FIG. 4 is attached to one
end of a flexible piston rod 63 constituted by a series of elements
65 interconnected by hinge means 66 (see FIGS. 13-15) and arranged
for movement between two guide walls 63a and 63b. The piston 64
abuts a displaceable wall or piston 66 of the carpule 58 such that
axial displacement of the piston 64 will press insulin out of the
carpule 58 into the catheter assembly 62.
The elements 65 are integral with each other by means of hinges 66
which allow adjacent elements to pivot relative to one another from
the position abutting one another shown in FIG. 14a wherein the
elements 65 together form a rectilinear piston rod with abutment
surfaces 65a and hinges 66 affording rigidity and thus rendering
the piston rod 63 capable of exerting a pressure on the piston 66
of the carpule without laterally deflecting, to the position shown
in FIG. 14b wherein the elements are pivoted way from one another
so as to allow the curvature of the piston rod 63 which allows the
compact configuration of the device with the initially major part
of the piston rod extending along the length of the carpule 68.
The material of the flexible piston rod 63 is any suitable moldable
material, but it is preferred that the material is a plastic
material such as Nylon or POM because of cost and re-cycling
issues.
Each element 65 is provided with exterior threads 67 on two opposed
portions 69 and 70 of the elements having a circular cylindrical
configuration for allowing an internal thread 71 of a pawl or
ratchet wheel 72 (FIG. 12) to mesh therewith such that rotation of
the pawl wheel 72 will displace the piston rod 63 into the carpule
58. At least the side of the elements 65 coinciding with the hinges
66 is flat to allow practical molding of the hinge. The flat side
or flat opposed sides also allows preventing rotation of the piston
rod 63 around its axis when being axially displaced by the internal
thread 71 of the pawl wheel 72
The pawl wheel 72 is rotated by a shape memory alloy actuator
comprising a wire 73 of a shape memory alloy such as Nitinol, one
end of which is attached to a rivet 74 and the other end of which
is attached to the free end of an actuator spring rod 75 by means
of a crimp 76. The wire 73 extends
around a pin 73a for change of direction. The free end of the
actuator spring rod 75 is located such that it meshes with the
teeth of the pawl wheel 72 and is biased by the spring force of the
rod to exert a spring force in the tangential direction (arrow R1)
and in the radial direction (arrow R2). Two end stop pins 77 and 78
limit the tangential movement of the actuator spring rod end
75.
A pawl spring rod 79 is located such that the end thereof meshes
with the teeth of the pawl wheel 72 and is biased to exert a spring
force in the radial direction (arrow R3). This end of the pawl
spring rod 79 is constrained to substantially only move in the
radial direction by two stop pins 80.
A battery 81 supplies power to the ends of the nitinol wire 73 for
heating it so as to cause it to contract. The battery 81 is
connected to the rivet 74 and the crimp 76 through a flexible
printed circuit film 82 on which is incorporated the control
circuits necessary for any programmed sequence of heating and
cooling of the wire 73 as well as any other electronically
controlled functions of the device.
Rotation of the pawl wheel 72 in the counter clock-wise direction
of the arrow R4 is brought about as illustrated in FIGS. 12a-12c.
In FIG. 12a the wire 73 is cool and expanded so that the actuator
spring rod end 75 is in its rightmost position abutting end stop
pin 78. The pawl spring end 79 locks the pawl wheel 72 against
clock-wise rotation.
In FIG. 12b the nitinol wire 73 has been heated and has contracted
thereby pulling the actuator rod end 75 to the left against the
spring forces R1 and R2 until it abuts the end stop pin 77.
In FIG. 12c the nitinol wire 73 has been cooled and the actuator
spring rod end 75 is rotating the wheel 72 counter clock-wise until
abutting end stop pin 78 again while the pawl rod end is ratcheting
against the spring force R3. Hereby, the pawl wheel has been
rotated the peripheral distance of one tooth thereof.
As the pawl wheel rotates, the internal thread 71 of the wheel
meshing with the threads 67 of the flexible piston rod elements 65
displaces the piston rod 63 into the carpule 58 for dispensing
insulin through the catheter 62.
The end stop pins 77 and 78 are electrically connected to the
flexible print board film 82 so that monitoring of the correct
function of the actuator may take place by registering electrical
contact between the end stop pins 77, 78 and the spring rod end 75
which indicates correct functioning of the actuator.
The flexible piston rod 63 could also be displaced by means of
another actuator, for instance such as described in connection with
the embodiment of FIGS. 1-4.
Referring now to FIG. 16, a carpule 58 identical to the one
described in connection with FIGS. 8-11 is located adjacent an
actuator generally referenced by the numeral 90 with a piston 91 of
the actuator abutting the not visible piston 66 of the carpule.
The piston 91 is attached to the end of a steel strip 92 having an
arcuate cross section taken at right angles to the longitudinal
direction of the strip. This arcuate shape entails a rigidity of
the strip 92 against lateral deflection such that the strip can
transmit pressure forces to the piston 91 without collapsing
because of lateral deflection.
A row of evenly spaced elongate apertures 93 are provided in the
strip 92 for receiving ribs 94 of a roller 95 having a gear 96
meshing with a worm gear 97. The worm gear is actuated by an
actuator that may be similar to the shape memory alloy actuators of
FIG. 6-7 or 8-12.
By rotating the worm gear 97 the gear 96 and roller 95 are rotated
whereby the ribs 94 received in the slits 93 unwind the strip 92
from the roll and displace it into the carpule whereby the piston
91 displaces the carpule piston and dispenses the insulin from the
carpule 58 that is located in the dispensing device in the same
manner as the carpule 58 of FIGS. 8-12.
A medicine dispensing device or insulin pump according to the
invention may function in several different manners depending on
the design and programming of the various control elements of the
circuit board 27:
1. Stand Alone Pump with Constant Flow:
The pump functions as a constant flow pump and may be designed for
different flow rates, for instance 20 units/24 hours, 30 units/24
hours, etc. By depressing the bolus button 3 and holding it down,
the pumping program is initiated and by again pressing the button 3
down and holding it, the pumping program is terminated while a
short duration pressure on the bolus button 3 activates a bolus
additional dosage of insulin of a certain magnitude.
FIG. 17 illustrates a possible programming of this type with the
line 100 indicating a constant flow corresponding to 50 units/24 hr
with a flow pause indicated at 101 between 20 and 21 hours after
start. Bolus extra dosages are indicated at 102 and 103. Other flow
rates are indicated with broken line graphs.
2. Stand Alone Pump with Varying Flow:
A timing device is incorporated in the printed circuit board 27 so
that a standard program controls the flow dispensed by the pump
during recurring 24 hour periods. The pre-programmed operating
instructions may for example result in a lower dosage at night than
during the day and an extra dosage at mealtimes.
FIG. 18 illustrates a possible programming of this type with the
graph 104 indicating night-time dosage 105, day-time dosage 106,
meal-time dosage 107, dosage pause 108 and bolus 109. Other dosage
programs are indicated in broken lines.
3. Programmable Pump Type 1:
The pump is not provided with a predetermined program, but is
provided with a programmable unit in the printed circuit board 27
and can be programmed by the user or a doctor by means of a
controller 29. The programming must be able to take place through
the packing material in which the dispensing device is supplied so
that the user can transport the device in a sterilized packaging on
vacations or the like without having to carry the controller along.
The controller is a dedicated unit that for instance via a USB plug
can be connected to a PC or it can be provided with cellular
telephone capability for transmission of data. The controller can
thus be programmed by a doctor or a user and be used for
programming of the functioning of all subsequently used disposable
dispensing devices.
4. Programmable Pump Type 2:
This pump functions in the same manner as programmable pump type 1,
but the controller is a personal data device such as the type
marketed under the trademark PALM PILOT.RTM., or a laptop PC. This
gives the additional advantage that the user may input health
information and glucose level measurement results directly into the
controller or programming unit and thus communicate such
information to the doctor who may use this information when
deciding whether the programming function of the controller or the
programming unit is to be altered for subsequently used disposable
dispensing devices.
5. Programmable Pump with Audio Input and Output:
By providing the dispensing device with the microphone/loudspeaker
28 and a suitable recording/play-back chip in the printed circuit
27, short messages may be recorded by the dispensing device, and
the short messages may be emitted by the device upon suitable
manipulation of the bolus push button 3 or a separate recording
button (not shown) mounted on the housing 2.
By means of this audio capability the user may record verbally
formulated information regarding glucose levels, meal composition,
exercise, etc. A timer may record the timing of each recorded
message. A doctor may then use these recorded messages together
with information about number and timing of bolus dosages, pumping
stops and the program utilized for the dispensing of the insulin so
as to evaluate the treatment and decide upon any changes in the
programming and instructions to the patient which may be recorded
by the doctor via a mobile telephone or the like such that messages
are automatically delivered to the user at predetermined times.
Such a message could for example be `remember to measure your
glucose level` (message program to be delivered by the dispensing
device to the user each morning at 8 o'clock) and so on.
Furthermore, standard instructions can be included in the
programming circuit so that the pump may deliver verbal messages to
the user instead of audio signals such as beep sounds. The message
could for instance be: `Pump is stopped` or `This is your third
bolus in a row and you have taken a total of eight bolus dosages
today` or `The pump will be empty in two hours` and so on.
Generally speaking, the audio capability described above will
render the dispensing device provided with such capability much
more user-friendly, especially for users initiating a treatment or
not very disciplined as regards compliance.
6. Closed Loop Re-Programmable Pump:
Either the controller or the computing unit mounted in the printed
circuit 27 may be programmed to react to information regarding
actual glucose blood level inputted by the user perhaps together
with other information, such as data regarding the timing and
constitution of the last meal, to alter the program of the
dispensing flow or dosage to take into consideration this
information such that the dispensing device to a certain extent
constitutes a closed loop, fuzzy logic, semi-automatic self
re-programming insulin dispensing device.
Referring now to FIG. 19, the graph illustrates a dispensing
program which may be used for the pumps type 3-6 where the flow
varies according to time and/or to input data.
The programming controller 29 may be a mobile wire-less
communication device such as a cellular telephone communicating
with the dispensing device by audio signals transmitted to and
received from the transmitter/receiver 28. The transmissions should
be preceded and terminated by an identification code to avoid
disruption of the programming of the device by extraneous audio
signals. Other signal identification or protection procedures such
as encryption may be utilized. The audio signals may be converted
to controlling signals for altering the programming of the
re-programmable computing unit mounted in the circuit board 27.
Signal conversion means may be provided for converting the audio
signals received by the receiver into input signals for the
computing means and for converting output signals from the
computing means into audio signals for being transmitted by the
loudspeaker.
Wire-less so-called SMS signals may also be utilized for
transferring information between a wire-less mobile communications
unit and the dispensing device, for instance by means of IR signals
or so-called Bluetooth communication technology.
Although the basic concept of the invention is that the entire
device is disposable, a variation may be that the
receiver/transmitter unit 28 with recording and play back
components and corresponding battery and perhaps circuit board with
computing means is reusable and may be releasably received in a
holder provided on the disposable portion of the device.
* * * * *
References